Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol

Scoliosis Clinical Trial

Official title:

Two-dimensional And Three-dimensional Measurements Of Torsion And Length Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Imaging Protocol Compared To Standard Dose Imaging Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332018
• Other study ID #: KEK-ZH-Nr.: 2014-0405
• Status: Completed
• Phase: N/A
• First received: January 5, 2015
• Last updated: February 17, 2017
• Start date: July 2014
• Est. completion date: January 6, 2016

Study information

• Verified date: February 2017
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol

Description:

Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol

Part 1: retrospective evaluation of 50 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 2: prospective evaluation of 100 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 3: prospective evaluation of 150 patients: spine images with MicroDose protocol and spine limb images with standard dose protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 6, 2016
• Est. primary completion date: January 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age)

Exclusion Criteria:

• Exclusion criteria: no informed consent

Related Conditions & MeSH terms

• Congenital Abnormalities
• Scoliosis
• Underdevelopment; Congenital Malformation, Lower Limb

Intervention

Radiation:
• Biplanar x-ray images
biplanar x-ray images with microdose and low-dose protocol

Locations

Country	Name	City	State
Switzerland	Radiology Department, Balgrist University Clinic	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without "MicroDose"-protocol and comparison of image quality parameters		12 month